PROJECT SUMMARY/ABSTRACT The Clinical Core provides both services and expertise and has a strong training component for cystic fibrosis (CF) research. The services focus on regulatory support, and study design and conduct support. We serve as a local, National and International resource to collaborators for advanced clinical trial design and conduct, biostatistical and epidemiologic methods and comparative effect research methods including cost-effectiveness analysis. The Core supports the central aims of the UW Cystic Fibrosis Research and Translation Center (CFRTC): to use highly effective modulator therapy (HEMT) initiation to discover novel aspects of cystic fibrosis (CF) pathophysiology, define the clinical manifestations and best treatment approaches for the ?new? disease that CF will become, and perform basic and translational research on disease aspects that persist despite HEMT. Further, the CC fosters collaboration across the CFRTC biomedical cores to enhance translational research through the sharing of existing and development of expanded human and bacterial repositories linked to clinical databases that enable development of improved assays and clinical outcome measures. We are well positioned to continue to advance novel therapeutics through the drug development pipeline and transition to major studies in CF that focus on improving our understanding of the disease in the setting of advancing therapeutics ? specifically HEMT that will forever change the clinical landscape in CF.